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NCT05811585 · ClinicalTrials.gov registry record
PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery
A clinical trial, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- 153
- Enrollment target
NCT05811585: Completed study, sponsored by Baxter Healthcare Corporation.
NCT05811585 is a clinical trial that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 153 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05811585 has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- 153 participants
- Enrollment target
Study Summary
Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.
Primary Outcome
Patient charts will be reviewed to collect data on readmissions related to adhesions, which are defined as: * Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract); * Possibly related to adhesions (gynecological operations, abdominal surgery, and non-operative readmissions); * Open or laparoscopic reoperations that could potentially be complicated by present adhesions.
Interventions
- DEVICE ADEPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2024-05-31 |
What the finished NCT05811585 record still lists
NCT05811585 is an observational study that tracks outcomes without assigning an intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which ADEPT is the first listed.
NCT05811585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05811585 about?
NCT05811585 is a clinical study titled "PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery". Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementione...
What is the current status of trial NCT05811585?
This trial is currently completed. The enrollment target is 153 participants. The study started on 2023-06-26. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT05811585?
The interventions under investigation include: ADEPT (DEVICE).
Who is sponsoring clinical trial NCT05811585?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
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